MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-09-19 for WALLFLEX DUODENAL M00565020 56436 manufactured by Boston Scientific Corporation.
[120824021]
Problem code captures the reportable event of stent material deformation. The device has not been received for analysis; therefore, a failure analysis of the complaint device could not be completed. If any further relevant information is identified, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[120824022]
It was reported to boston scientific corporation on (b)(6) 2018 that a wallflex duodenal stent was to be used to treat a 5cm malignant stricture in the superior part (d1) of the duodenum during a stent placement procedure performed on (b)(6) 2018. Reportedly, the patient's anatomy was not tortuous and was not dilated prior to stent placement. According to the complainant, during the procedure, the stent was able to be deployed. However, after deployment, the stent shrunk and was pushed together when viewed endoscopically. The stent was immediately removed with forceps and another wallflex duodenal stent was placed to complete the procedure. There were no patient complications reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2018-60453 |
| MDR Report Key | 7891683 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-09-19 |
| Date of Report | 2018-11-16 |
| Date of Event | 2018-08-20 |
| Date Mfgr Received | 2018-10-24 |
| Device Manufacturer Date | 2018-06-28 |
| Date Added to Maude | 2018-09-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CAROLE MORLEY |
| Manufacturer Street | 300 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086834015 |
| Manufacturer G1 | BOSTON SCIENTIFIC IRELAND LIMITED |
| Manufacturer Street | BALLYBRIT BUSINESS PARK |
| Manufacturer City | GALWAY |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WALLFLEX DUODENAL |
| Generic Name | STENT,METALLIC,EXPANDABLE,DUODENAL |
| Product Code | MUM |
| Date Received | 2018-09-19 |
| Returned To Mfg | 2018-09-28 |
| Model Number | M00565020 |
| Catalog Number | 56436 |
| Lot Number | 0022312712 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | 300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-09-19 |